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临床试验/NCT05082506
NCT05082506Unknown不适用

Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography: A Randomized Controlled Study

Eastern Mediterranean University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
105
试验地点
1
主要终点
Spielberger State Anxiety Scale

研究概览

简要总结

The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography. Acupressure application was carried out by the responsible researcher, who is certified on this subject, by TRNC Dr. In the Cardiology Service of Burhan Nalbantoğlu Hospital, patients who have undergone angiography will be applied and measurements will be made before mobilization after their informed consent is obtained.

详细描述

In this study, it is aimed to raise awareness for the use of painless, painless, economical, side-effect-free and easy-to-apply acupressure in nursing care in order to increase patient comfort by relieving pain and anxiety of patients during mandatory bed rest after coronary angiography. In addition, our study is important in terms of providing new information with a high level of evidence and providing a source for other studies on this subject.

Objective: The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography.

Hypothesis 1 H0: There is no difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

H1: There is a difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

Hypothesis 2 H0: There is no difference between the Spielberger State Anxiety Inventory mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

As a result of the draw, group A was determined as acupressure, group B as sham acupressure and group C as the control group. Since pressure will be applied to the pressure points of the patients in the acupressure and sham group included in the study, the sham (placebo) acupressure and acupressure groups will be blinded, since the patients do not know whether acupressure or sham acupressure is applied. The control group and the researcher cannot be blinded due to the nature of the research.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •First time coronary angiography performed
  • •Coronary angiography performed from the femoral region,
  • •over the age of 18,
  • •Willing to participate in the research,
  • •Able to understand and speak Turkish,
  • •Open to communication,
  • •Planned (non-urgent) coronary angiography
  • •No complications after angiography
  • •Stent etc. during angiography. no other attempt has been made
  • •No deformity or lesion in the areas where acupressure will be applied
  • •Not taking sedatives or pain relievers 5 hours before the angiography procedure,
  • •No acupressure experience
  • •Not diagnosed with anxiety disorder and not receiving medical treatment
  • •Not diagnosed with depression and not receiving medical treatment
  • •No chronic pain
  • •Patients without mental illness.

排除标准

  • •- Previous coronary angiography
  • •Coronary angiography from the femoral region is not performed,
  • •under the age of 18,
  • •pregnant,
  • •Those who do not agree to participate in the research,
  • •Can't understand or speak Turkish,
  • •Unable to communicate
  • •Unplanned (urgent) Coronary angiography Patients
  • •Any complications after angiography
  • •Stent etc. during angiography. another attempt has been made
  • •Any deformity or lesion in the areas where acupressure will be applied,
  • •Those who took sedatives or painkillers 5 hours before the angiography procedure,
  • •Experience with acupressure
  • •Anxiety disorder and receiving treatment,
  • •Diagnosed with depression and receiving treatment,
  • •Having chronic pain,
  • •Patients with mental disorders.

研究组 & 干预措施

Acupressure Group

Experimental

Applicable to the acupressure group; Heart meridian 7th point (HT7), large intestine meridian 4th point (LI4) and pericardium 6th point (PC6), a total of three points will be applied. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Since the symmetry of the selected three different points on the other extremity will also be applied, a total of 12 minutes of compression will be applied to each point, provided that it is two minutes. Depending on the preparation and compression time on each point, the session duration of each patient will be approximately 16 minutes.

干预措施: Acupressure (Behavioral)

Sham Group

Placebo Comparator

n the acupressure application to the Sham group, pressure will be exerted on the bone region where the meridians do not pass, parallel to the HT7, LI4, PC6 and points (approximately 1-1.5 cm away) (Figure 4). Before the application, the acupressure points will be heated for about 20 seconds and the tissue sensitivity will be reduced by rubbing and they will be made ready for the acupressure application. Afterwards, the acupressure points determined will be pressed with the thumb by the researcher with a lower intensity than the normal application pressure for two minutes. Similar to the acupressure group, the sham group will be applied to symmetrical points. In this direction, a session will last 16 minutes for each patient, as in the acupressure group, together with the duration of the pre-procedure preparation and applications.

干预措施: Acupressure (Behavioral)

Control Group

No Intervention

Patients in the control group will not receive any intervention.

结局指标

主要结局

Spielberger State Anxiety Scale

时间窗: 6 month

The scale consists of 20 statements. The total score can range from 20 to 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

次要结局

  • Visual Pain Scale(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Bal

SENİOR İNSTRUCTİON

Eastern Mediterranean University

研究点 (1)

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